Monday, May 23, 2011

Chantix Implicated in Suicide; How Many Will It Take Before Anti-Smoking Groups that Demand E-Cigs Be Pulled From Market Also Call for Chantix Ban?

Chantix has been implicated in yet another suicide. This time, it is a tragic murder-suicide. The fathers of the two people killed have filed a lawsuit against Pfizer blaming Chantix for the deaths of their loved ones.

According to an article on the WTAE (Pittsburgh) web site: "The lawsuit contends New York-based Pfizer didn't sufficiently warn consumers until after the murder-suicide, even though those side effects were allegedly revealed during clinical trials. 'They clearly knew about it before this event. In fact, within a few weeks of Sean and Natalie's deaths, Pfizer was required to post a black box warning on the product,' said Pribanic [the attorney representing the plaintffs]. The lawsuit claims Chantix causes an "increased risk of death, including depression, agitation, hostility, rage and suicide." 'It makes some people, for reasons yet to be demonstrated, people who would otherwise never entertain such an idea, want to kill other people or themselves or both,' said Pribanic."

"Pfizer told Channel 4 Action News that 'We have not yet reviewed the circumstances of this case, but no causal relationship has been found between the medicine and neuropsychiatric events such as those alleged here.' The drug company said it received "post-marketing reports" of such symptoms that don't scientifically "establish a cause and effect relationship" between the medicine and such behavior. Pfizer said it warns users and their doctors to monitor "neuropsychiatric symptoms," and that patients who become hostile, aggressive or suicidal should immediately stop using the drug."

"In 2008, the Institute for Safe Medication Practices or ISMP issued a report that blamed Chantix for 1,001 serious incidents involving users of the medication in the first quarter of that year. At the time, the ISMP said that's more adverse events than reported for any other prescription drug...Pfizer issued a statement at the time that said the ISMP's "report was based solely on a tally of post marketing adverse events.... Such reports are often unverifiable and lack sufficient medical information to draw any conclusions."

The Rest of the Story

In light of the thousands of serious adverse events involving users of Chantix and the apparent fact that Pfizer is undermining its own warnings by denying any causal association between Chantix and the reported events, why is it that the anti-smoking groups which have called for electronic cigarettes to be pulled from the market are not calling for Chantix to also be pulled?

While Chantix has been associated with thousands of serious incidents and more than 100 deaths, electronic cigarettes have not been implicated in any. While there is abundant evidence that Chantix can cause severe psychiatric symptoms shortly after the drug is initiated, there is no evidence that electronic cigarettes cause any serious adverse effects.

The anti-smoking groups which have called for e-cigs to be banned have argued that electronic cigarettes must be proven safe before being allowed on the market. Why does the same not hold for Chantix? Why should this drug continue to be marketed even though it has clearly not been shown to be safe? Since both are products already on the market, why should a different standard apply to electronic cigarettes than to Chantix?

In my opinion, there are two answers.

1. Money

Every one of the anti-smoking groups which have called for a ban on electronic cigarettes has received funding from pharmaceutical companies that manufacture smoking cessation drugs, including Pfizer itself.

Pfizer reports a large number of grants in 2010 to the American Cancer Society, American Heart Association, American Lung Association, American Academy of Pediatrics, and Campaign for Tobacco-Free Kids here.

Additionally, Pfizer reports grants in 2009 to the American Legacy Foundation, along with the American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, Action on Smoking and Health, and American Academy of Pediatrics here.

Clearly, Pfizer's donations are being well-spent, because they are deflecting attention from Chantix and its dangers and leading to silence from the anti-smoking groups regarding the risks of Chantix, even though the very same groups demanded that electronic cigarettes be pulled from the market in the absence of any reported serious adverse effects.

In making their pronouncements against electronic cigarettes, these groups have not even disclosed their financial conflicts of interest, thus violating basic ethical principles on top of displaying inconsistency in their actions.

2. Ideology

The ideology is simply this: nothing that looks like cigarette smoking can possibly be a good thing, even if it saves lives. People need to quit smoking the way we say they should quit smoking. There is a right way and a wrong way to quit smoking. The right way is our way and the wrong way is any other way. If it looks like smoking, it's still smoking, even if there are no adverse health effects and the individual has achieved smoking cessation.

These anti-smoking groups can simply not tolerate the fact that a product which simulates smoking could possibly be a good thing and that they cannot possibly endorse such a product, even though the product is already saving lives and could potentially save millions of lives if broadly promoted among the population of current smokers.

If anti-smoking groups want to argue that any smoking cessation product on the market has to first be unequivocally proven safe, then fine. They can argue that e-cigarettes should be removed from the market but they must also call for Chantix to be pulled from the market for the same reason.

Alternatively, if they believe that the burden of proof is on others to demonstrate that Chantix is unsafe before pulling it from the market, then that's fine too. But then they must apply the same reasoning to electronic cigarettes and ask that these products remain on the market until such time as they are demonstrated to be unreasonably unsafe.

The glaring inconsistency in the policies being espoused by the anti-smoking groups is a glaring revelation of the influence of pharmaceutical money combined with the stifling effects of wearing ideological blinders.

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About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.